The National Institutes of Health (NIH) has finalized the requirements for submitting clinical trial information for applicable clinical trials of drug products (including biological products) and device products on ClinicalTrials.gov. The rule is intended to clarify as well as establish additional procedures and requirements for submitting: (i) registration, (ii) summary results, and (iii) adverse event information for such applicable clinical trials.
According to NIH, the expanded registry and results data bank will “help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research.” Among other things, the final rule:
- Clarifies which clinical trials are subject to the regulations and as such, must register or have their result information submitted on ClinicalTrials.gov. In short, the final rule considers all interventional clinical trials with one or more arms and with one or more pre-specified outcome measures to be controlled clinical trials; expanded access use is not considered an applicable clinical trial.
- Requires registration of any applicable clinical trial that is initiated (i) after September 27, 2007, or (ii) on or before September 27, 2007 that is ongoing on December 26, 2007. The applicable clinical trial must be registered not later than December 26, 2007 or 21 calendar days after enrolling the first human subject, whichever date is later. The rule also specifies the data elements that must be submitted at the time of registration (including a requirement for the reporting of race and ethnicity information, or an indication that such information was not collected during the trial).
- Expands the scope of trials for which summary results information must be submitted to include trials involving FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA. Results generally must be submitted no later than 1 year after the completion date of the clinical trial. Results information submission could be delayed or waived in certain circumstances.
- Specifies the party responsible for submitting the clinical trial registration information and the results information. In general, the sponsor of an applicable clinical trial will be considered the responsible party, unless and until the sponsor designates a qualified principal investigator as the responsible party.
- Requires the responsible party to submit a separate expanded access record containing details on how to obtain access to the investigational product being studied if such expanded access is available. This information must be submitted along with the registration information and it only applies if the sponsor of the clinical trial is also the manufacturer of the investigational product.
- Requires the responsible party to submit information summarizing the number and frequency of adverse events experienced by participants enrolled in a clinical trial, by arm or comparison group, and specifies the form of that reporting.
- Requires all submitted information to be updated at least annually if there are changes to report, with provisions for more rapid updating in certain circumstances.
- Specifies the potential civil or criminal actions, civil monetary penalties, and grant funding actions that may be taken if responsible parties fail to comply with the rule.
The final rule does not impose requirements regarding the design or conduct of clinical trials or the data that must be collected during clinical trials. Nevertheless, CMS expects the rule to result in $59.6 million in annual costs. The rule, which was published on September 21, 2016, is effective on January 18, 2017. Responsible parties will have 90 days after the effective date to come into compliance with the rule.